Official Title: “MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride Add-on Study for Patients With Type 2 Diabetes Mellitus”

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD
• Drug: Sitagliptin phosphate
  • Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: P
• Experimental: E

Primary Measures

• HbA1c
  • Time Frame: 12 weeks
    Safety Issue?: No
• safety
  • Time Frame: 52 weeks
    Safety Issue?: Yes
• tolerability
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Plasma glucose
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion Criteria:

• Patients with Type 1 diabetes mellitus

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ono Pharma

Overall Clinical Trial Officials and Contacts

Mikio Nishii Study Director Ono Pharma  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00363519

Study ID Number: ONO-5435-09

ClinicalTrials.gov Identifier: NCT00363519

Health Authority: Japan: Ministry of Health, Labor and Welfare